Prostate Cancer
Conditions
Keywords
Prostate Cancer, Proton Radiation
Brief summary
The purpose of this trial is to give a shorter course (5 ½ weeks) of radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of radiation, without decreasing the chance of killing prostate cancer cells.
Detailed description
Low Risk - Total of 70 Gy/CGE over 28 treatments Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments
Interventions
RADIATIONLow Risk Proton Radiation
RADIATIONIntermediate Risk Proton Radiation
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prostate cancer. * Gleason score 2-7. * PSA ≤ 20 ng/ml.
Exclusion criteria
* Previous prostate cancer surgery or pelvic radiation. * Prior or current chemotherapy for prostate cancer. * Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. * History of proximal urethral stricture requiring dilatation. * History of hip replacement. * Diabetes requiring medication. * Prior intrapelvic surgery. * Current and continuing anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox). * On Flomax (Tamsulosin), Hytrin (Terazosin) or Cardura (Doxazosin), Uroxatral (alfuzosin HCl). * Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate. | 6 months after the end of radiation therapy |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control | 20 years after end of radiation |
Countries
United States
Participant flow
Recruitment details
University of Florida Proton Therapy Institute, between 04/2008 and 04/2010
Participants by arm
| Arm | Count |
|---|---|
| Low Risk Proton Radiation 70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx | 122 |
| Intermediate Risk Proton Radiation 72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx | 106 |
| Total | 228 |
Baseline characteristics
| Characteristic | Intermediate Risk Proton Radiation | Low Risk Proton Radiation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 62 Participants | 62 Participants | 124 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 60 Participants | 104 Participants |
| Age, Continuous | 64.1 years STANDARD_DEVIATION 6.9 | 65.3 years STANDARD_DEVIATION 7.5 | 64.7 years STANDARD_DEVIATION 7.2 |
| Region of Enrollment United States | 106 participants | 122 participants | 228 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 106 Participants | 122 Participants | 228 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 122 | 21 / 106 |
| serious Total, serious adverse events | 2 / 122 | 2 / 106 |
Outcome results
Primary
Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.
Time frame: 6 months after the end of radiation therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Risk Proton Radiation | Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate. | 0 Participants |
| Intermediate Risk Proton Radiation | Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate. | 0 Participants |
Secondary
Disease Control
Time frame: 20 years after end of radiation